Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

f86a015b-22d1-43a5-ab55-781b21f2976a

Public Version Date

April 18, 2022

Public Version Number

2

DI Record Publish Date

November 18, 2021

Package DI Number

60368001100153

Quantity per Package

10

Contains DI Package

00368001100151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case